Biosystems

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K192730CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UVSeptember 9, 2020
K190495TransferrinMarch 16, 2020
K182474alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTALMay 2, 2019
K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400April 13, 2018
K950897BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE)August 24, 1995
K950898BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE)August 24, 1995
K950899LABORATORY SHARPS BARRELJune 29, 1995